Device Classification Name |
Neurosurgical Nerve Locator
|
510(k) Number |
K152942 |
Device Name |
NuVasiveNVM5 System |
Applicant |
NUVASIVE INCORPORATED |
7475 LUSK BOULEVARD |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
Olga Lewis |
Correspondent |
NUVASIVE INCORPORATED |
7475 LUSK BOULEVARD |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
Olga Lewis |
Regulation Number | 874.1820
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/05/2015 |
Decision Date | 01/13/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|